Clinical Trials Register

Summary
EudraCT Number:	2008-004439-39
Sponsor's Protocol Code Number:	0881X1-4535-WW
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-02-19
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2008-004439-39

A.3

Full title of the trial

Randomized Open-label Study Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded to Etanercept Treatment

A.3.2

Name or abbreviated title of the trial where available

ReSPONSE

A.4.1

Sponsor's protocol code number

0881X1-4535-WW

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	ENBREL*SC 4SIR 25MG 0,5ML+8TAM
D.2.1.1.2	Name of the Marketing Authorisation holder	WYETH LEDERLE SpA
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ETANERCEPT
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	ENBREL*SC 4SIR 50MG 1ML+8TAMP
D.2.1.1.2	Name of the Marketing Authorisation holder	WYETH LEDERLE SpA
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ETANERCEPT
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Plaque psoriasis.

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10037153
E.1.2	Term	Psoriasis

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To describe the effect on subjects in whom PSO has responded to initial treatment with ETN of 2 different strategies for managing a good response or complete response (PGA = 1or 0) over a 52-week time period.

E.2.2

Secondary objectives of the trial

- To compare the efficacy of the 2 different strategies by reference to quality of life (QoL) measure over the duration of the study. - To explore the time course of severity following treatment modification. - To explore the degree of subject satisfaction with the 2 different options for management following successful initial treatment.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Eighteen (18) years of age or older at time of consent. - Previously treated with ETN for chronic plaque PSO for at least 20 weeks prior to the screening visit, who are documented to have been on a total weekly dose of 50 mg per week for at least the 6 weeks preceding the day of the screening visit - Having shown clinical response with a PGA 1 at the screening visit. - With a PGA 1 at the baseline visit. - Where the last injection of ETN was performed not more than 7 days before the baseline visit. - Able to store the injectable investigational product under refrigerated conditions. - Able to self-inject investigational product or have a designee who can do so. - Able to complete health outcome assessments and any study diaries. - Demonstrates an adequate screening for tuberculosis (TB) in accordance with local country guidelines, since ETN has been prescribed, tests results and/or radiographic report must be available at site. - Is a man or woman who is surgically sterile or is at least 1 year postmenopausal. A woman not surgically sterile or at least 1 year postmenopausal must demonstrate a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline, and must agree and commit to use medically acceptable forms of contraception. All female subjects who are also taking known teratogens, eg methotrexate, acitretin, must agree and commit to use contraceptive precautions as recommended by the respective SPCs, data sheets or equivalent legal documents. In addition, all male subjects taking concomitant methotrexate who are biologically capable of having children must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of methotrexate.

E.4

Principal exclusion criteria

- Evidence of skin conditions (eg, eczema) other than PSO that would interfere with evaluations of the effect of study medication on PSO. - Evidence of active or previously known medical history of inflammatory arthritis. - Any biologics other than ETN within the 20 weeks prior to the screening visit. - Ciclosporin, within 28 days of the baseline visit. - Received isoniazid (INH) therapy during screening and has had the mandatory liver function test (LFT) profile before the baseline visit that is out of the normal lab range. (Note: the liver function test profile blood samples must be drawn after initiating isoniazid therapy at a minimum of 3 weeks and at least 4 days prior to the planned baseline visit). - Receipt of any live (attenuated) vaccine within 4 weeks before baseline. - Sunbathing or UV treatment for therapeutic reasons (ultraviolet light A [UVA], psoralen and ultraviolet light A therapy [PUVA], or ultraviolet light B [UVB] therapy, including narrow band UVB and excimer laser) within 28 days of the baseline visit. - Oral, intravenous, intramuscular, intra-articular, and subcutaneous (SC) corticosteroids within 28 days of the baseline visit. Exception: inhaled corticosteroids for the treatment of pulmonary conditions and topical ophthalmic solutions containing corticosteroids with or without antibiotics for episodes of acute ocular inflammation are permitted. - Abnormal hematology or blood chemistry profile: - hemoglobin ≤85 g/L; - hematocrit ≤27%; - platelet count ≤125 x 109/L; - white blood cell count ≤3.5 x 109/L; - serum creatinine (Creat) ≥175 μmol/L; - aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≥2 times the laboratory s upper limit of normal (ULN). - Clinically relevant concurrent medical events including: - Serious infection (infection associated with hospitalization and/or intravenous antibiotics) within 1 month before investigational product administration or active infection at screening, including known human immunodeficiency virus (HIV) infection. - Active or recent (within 2 years) TB infection (Note: local country guidelines should be followed for appropriate screening and prophylaxis in the setting of anti-tumor necrosis factor (TNF) therapy including a minimum of a chest radiograph and /or objective TB testing, such as purified protein derivative (PPD) or Quantiferon depending on what is acceptable per local guidelines). Subjects with latent TB infection may be allowed only if local guidelines are followed for prophylactic therapy and if treatment is initiated before therapy, followed by proof that no adverse drug reaction has occurred with the anti-TB medications. - Uncontrolled hypertension (defined as screening systolic blood pressure >160 mm Hg or screening diastolic blood pressure >100 mm Hg). - Myocardial infarction within 12 months of the screening visit. - Unstable angina pectoris within 6 months of the screening visit. - Class III or IV congestive heart failure as defined by the New York Heart Association [see Attachment 1]. - Severe pulmonary disease requiring hospitalization or supplemental oxygen within 12 months of screening. - Known history or presence of hepatitis B or hepatitis C infection, including known presence of alcoholic hepatitis - History of human immunodeficiency virus (HIV) infection, immunodeficiency syndromes - Diagnosis of multiple sclerosis or other central or peripheral nervous system demyelinating diseases - Presence or history of confirmed blood dyscrasias - Uncontrolled diabetes mellitus - Open cutaneous ulcers - Presence or history of cancer (or carcinoma in situ) other than resected cutaneous basal cell or squamous cell carcinoma within the past 5 years before the screening visit - Known contraindication or hypersensitivity to ETN or its excipients...

E.5 End points

E.5.1

Primary end point(s)

Average 52-week PGA (measured as the time-normalized area under curve).

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Confronto tra il braccio d`interruzione e manten.

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	48
F.4.2	For a multinational trial
F.4.2.1	In the EEA	290
F.4.2.2	In the whole clinical trial	298

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2010-08-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-02-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-04-23

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